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NCT07383649 · ClinicalTrials.gov registry record · Phase 2
Trial to Study Anti- HCMV Therapy in Breast Cancer Patients With Progressive Intracranial Metastases and CMV Infection
A Phase 2 study of CMV Viremia and Brain Cancer Metastatic, sponsored by The Methodist Hospital Research Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT07383649 is a Phase 2 study of CMV Viremia and Brain Cancer Metastatic that is actively recruiting participants, run by The Methodist Hospital Research Institute. The registered enrollment target is 28 participants. The trial reports 1 study location across 1 state.
The verdict
NCT07383649, a Phase 2 study of CMV Viremia and Brain Cancer Metastatic, is actively recruiting participants, sponsored by The Methodist Hospital Research Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a phase II trial with an initial safety lead-in evaluating the efficacy, safety, neurocognitive, and quality-of-life outcomes of anti-cytomegalovirus (CMV) therapy and standard-of-care (SOC) in patients with anti-human cytomegalovirus (HCMV)-reactivated brain metastases. Male and female patients, aged ≥18 years, who have metastatic breast cancer with progressive brain metastases and CMV viremia (\> 250 copies/ml) or positive CMV IgG or IgM will be eligible to participate in the trial. Patients can proceed with SRS as long as at least 1 lesion which is 2 cm or less in a noncritical area in the brain is spared as per the discretion of treating neurosurgeon/radiation oncologist. At least 10 patients will be enrolled in the initial safety lead-in followed by the Phase II trial which will include 18 patients. Anti-HCMV therapy, oral Valganciclovir will be given to patients at 900 mg twice a day for 2 weeks. After the induction period, the maintenance will be continued with valganciclovir at 450 mg twice daily for 4 weeks (28 days).
Conditions Studied
Interventions
- DRUG Valganciclovir
Study Locations (1)
Texas
- Houston Methodist Neal Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2026-03 |
| Est. Completion | 2030-05 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07383649
The ClinicalTrials.gov registry entry for NCT07383649 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Methodist Hospital Research Institute, which has 126 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with CMV Viremia appearing as the primary indexed condition, and to 1 intervention - of which Valganciclovir is the first listed.
NCT07383649 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT07383649 about?
NCT07383649 is a clinical study titled "Trial to Study Anti- HCMV Therapy in Breast Cancer Patients With Progressive Intracranial Metastases and CMV Infection". This is a phase II trial with an initial safety lead-in evaluating the efficacy, safety, neurocognitive, and quality-of-life outcomes of anti-cytomegalovirus (CMV) therapy and standard-of-care (SOC) in patients with anti-human cytomegalovirus (HCMV)-reactivated brain metastases. Male and female pati...
What is the current status of trial NCT07383649?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2026-03. Estimated completion is 2030-05.
What conditions does trial NCT07383649 study?
This clinical trial studies the following conditions: CMV Viremia, Brain Cancer Metastatic.
What interventions are being tested in trial NCT07383649?
The interventions under investigation include: Valganciclovir (DRUG).
Who is sponsoring clinical trial NCT07383649?
This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07383649 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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